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Esophageal cancer is the seventh most common type of cancer in the world, with an estimated global incidence of 604,100 new cases per year. The main symptom of esophageal cancer is dysphagia, associated or not with weight loss. Unfortunately, due to asymptomatic presentation in the early stages, more than half of patients are diagnosed in advanced stages of the disease, becoming ineligible for treatment with curative intent. In this sense, chemotherapy and radiotherapy are the pillars of palliative treatment, often regressing the injury and improving symptoms. However, some patients persist with dysphagia. In this scenario, esophageal prostheses are one of the main tools in the palliative treatment of esophageal cancer dysphagia, obtaining rapid and lasting relief of dysphagia. This study aims to compare fully covered (FC-SEMS) and partially covered (PC-SEMS) esophageal prostheses in this context, evaluating the number of reinterventions in each group, as well as the occurrence of adverse events. However, it is expected that with the data obtained it is possible to develop clearer and more effective protocols in the palliation of malignant dysphagia of esophageal stenosis.
STUDY DESIGN: Prospective and randomized study will be conducted.
PREPARATION AND TECHNICAL STEPS OF THE PROCEDURE: The placement of the esophageal prosthesis will be performed under sedation or general anesthesia supervised by the anesthesiologist at the endoscopy service of the Cancer Institute of the State of São Paulo (ICESP). The tests will be performed under radioscopic control. The tests will be performed on an outpatient basis, and hospitalization may occur in case of clinical need.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | placement of the esophageal prostheses fully covered in the palliative treatment of malignant esophageal obstructions. |
|
| Group B | Active Comparator | placement of the partially covered esophageal prostheses in the palliative treatment of malignant esophageal obstructions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fully Covered Esophageal Prosthesis (FC-SEMS) | Device | The placement of the Fully Covered Esophageal Prosthesis (FC-SEMS) will be performed under sedation or general anesthesia supervised by the anesthesiologist at the endoscopy service of the Cancer Institute of the State of São Paulo (ICESP). The tests will be performed under radioscopic control. The tests will be performed on an outpatient basis, and hospitalization may occur in case of clinical need. |
| Measure | Description | Time Frame |
|---|---|---|
| Reinterventions | Number of reinterventions after the procedure. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and patency time of the prostheses | Number of adverse events | 2 years |
| Patency time of the prostheses. | Days without need a new prothesis or procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fauze Maluf-Filho, PhD | Contact | +5511991919014 | fauze.maluf@terra.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Fauze Maluf-Filho, PhD | Cancer Institute of the state of São Paulo (ICESP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Câncer do Estado de São Paulo | Recruiting | São Paulo | São Paulo | 01246-000 | Brazil |
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|
| Partially Covered Esophageal Prosthesis (PC-SEMS) | Device | The placement of the Partially Covered Esophageal Prosthesis (PC-SEMS) will be performed under sedation or general anesthesia supervised by the anesthesiologist at the endoscopy service of the Cancer Institute of the State of São Paulo (ICESP). The tests will be performed under radioscopic control. The tests will be performed on an outpatient basis, and hospitalization may occur in case of clinical need. |
|
| 2 years |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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